Onyx™ Liquid Embolic IDE Clinical Study
PELE IDE Clinical Study, Peripheral Onyx™ Liquid Embolic Safety and Effectiveness of The Onyx™ LES for Embolization of Arterial Hemorrhage in the Peripheral Vasculature
Medtronic Endovascular
119 participants
May 9, 2025
INTERVENTIONAL
Conditions
Summary
The purpose of this study is to evaluate the safety and effectiveness of Onyx™ LES in the treatment of subjects with active arterial bleeding in the peripheral vasculature outside of the heart and brain.
Eligibility
Inclusion Criteria6
- Patient is ≥ 22 years old.
- Active arterial bleeding in the peripheral vasculature confirmed by radiologic and/or endoscopic imaging and deemed suitable for embolization treatment by the investigator.
- In this study, peripheral vasculature is defined as outside the brain and heart.
- Patient or legally authorized representative (LAR) is able to provide written consent to participate in the study.
- Life expectancy of \>30 days, in the opinion of the investigator at the time of enrollment.
- Target treatment area is free from prior embolization treatment.
Exclusion Criteria7
- Pregnant or breastfeeding.
- Symptoms of active infection.
- Patient is known to be participating in the study of an investigational drug, biologic, or device.
- Contrast allergy or other contraindication to angiography, CT, or catheterization, including contrast sensitivity that cannot be adequately treated prior to index procedure.
- Known allergy to components of Onyx™.
- Target vasculature unsuitable for the delivery of Onyx™ based upon physician assessment.
- More than 4 target lesions will require embolization, in the investigator's opinion after imaging-based assessment.
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Interventions
The proposed indication for Onyx™ LES is: Onyx™ LES is indicated for the embolization of arterial hemorrhage in the peripheral vasculature.
Locations(14)
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NCT06742801